UK responsible person for Great Britain: authority, evidence and labelling scope
Use this guide to scope written authority, controlled document access, registration ownership and label review for a possible Great Britain appointment. Confirm the manufacturer establishment, intended GB or NI supply, device regime and marking before deciding applicability; this page does not resolve Northern Ireland or a particular device transition. The acquired MHRA guidance distinguishes a non-UK manufacturer’s Great Britain appointment from the importer/distributor role and Northern Ireland’s regime. It describes written authority, registration, retained conformity documents and MHRA cooperation. Scope these tasks and the actual label/marking arrangement; public registration is not approval or endorsement.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Sourced criteria · GB
What changes the service scope?
Decision or task
What the source describes
What to prepare
Whose appointment is being assessed?
The guidance addresses manufacturers outside the UK placing devices on the Great Britain market; importers/distributors are a different role. Northern Ireland has different rules. [1][3][10]
Map manufacturer establishment and intended GB/NI markets separately, including any combined importer/RP service.
What authority and registration work is agreed?
The guidance specifies written authority and describes registering the represented manufacturer’s devices with MHRA. [2][4]
Agree the covered devices, registration access/ownership and written authorisation; distinguish this from a product approval claim.
What evidence and escalation are retained?
The guidance describes conformity documentation checks, available copies, MHRA information and manufacturer notification of complaints/incidents. [5][6][7][8]
Specify document versions, access, request handling and complaint escalation rather than relying on an address-only service.
How does marking affect the RP label task?
The guidance distinguishes UKCA-affixed cases, CE-only cases and dual marking for UK responsible-person labelling. [9]
Review actual artwork and applicable marking before a label update; do not copy EU or NI labels unchanged.
The device’s regime, marking, transition facts and current legislation remain incomplete. This is dated MHRA guidance for GB scope, not a combined GB/NI/EU determination or MHRA endorsement.
Great Britain appointment and evidence handoff
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Whose appointment is being assessed?
Map manufacturer establishment and intended GB/NI markets separately, including any combined importer/RP service.
Useful evidence: Manufacturer identity/establishment, market list and actor responsibility matrix.
Conditional: GB appointment, registration and controlled evidence access — Preparation tasks to agree: Map manufacturer establishment and intended GB/NI markets separately, including any combined importer/RP service. Agree the covered devices, registration access/ownership and written authorisation; distinguish this from a product approval claim. Specify document versions, access, request handling and complaint escalation rather than relying on an address-only service. Review actual artwork and applicable marking before a label update; do not copy EU or NI labels unchanged. This package remains conditional until the deciding facts and exclusions are agreed.
Questions for providers
Which exact actor, product or processing facts support the quoted scope, and what is still unresolved?
How will the listed records reach the responsible people, and who owns each change or authority request?
Which tasks and entities are excluded from the agreement, and which additional services need a separate assessment?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
